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Researchers at the University at Buffalo are about to launch North America's first clinical trial to test the "liberation treatment," an experimental therapy designed to halt the symptoms of multiple sclerosis.

The landmark prospective, randomized, double-blinded study will test both the safety and efficacy of the endovascular therapy on MS symptoms and progression.

The researchers will examine whether dilating blocked neck veins in MS patients using angioplasty remedies the blockages and improves MS symptoms or progression.

The first leg of the University at Buffalo trial will take two days and will begin Tuesday. Ten patients have already been selected to receive the treatment. They will then be followed for 30 days of analysis to measure the side effects and possible risks of the procedure.

The study will be led by Dr. Adnan Siddiqui and colleagues at the University at Buffalo's Department of Neurosurgery.

Depending on the results, researchers will then embark on Phase 2, which will randomize another 20 MS patients to undergo either angioplasty or a "sham angioplasty" (i.e. a catheter will be inserted but there will be no inflation of the balloon).

Hospital officials say the treatment will be blinded and performed in a way that "neither the patient undergoing the procedure nor the clinicians evaluating the patient will be aware which procedure was performed."

If results suggest the procedure is safe and effective, researchers will apply to study a larger number of patients.

http://ottawa.ctv.ca/servlet/an/local/C ... OttawaHome

The study is being led by principal investigator Dr. Adnan Siddiqui along with co-principal investigators Dr. Elad Levy and Dr. L.N. Hopkins of the University at Buffalo Department of Neurosurgery. Additional independent researchers from University at Buffalo will participate in the evaluation and follow-up of study patients. An independent Data Safety Monitoring Board (DSMB) will ensure the safety and effectiveness of the study on an ongoing basis.

In the first phase of the study, ten MS patients from the United States and Canada exhibiting venous insufficiency will undergo minimally invasive venous angioplasties to determine if the procedure can be performed safely. The procedures, scheduled for June 29 and 30, 2010, will be performed by Drs. Siddiqui and Levy at Kaleida Health’s Millard Fillmore Gates Hospital in Buffalo, New York.

The second phase of the study will randomize 20 MS patients to undergo either venous angioplasty or a “sham angioplasty” (i.e. a catheter will be inserted but there will be no inflation of the balloon). The treatment will be blinded in such a way that neither the patient undergoing the procedure nor the clinicians evaluating the patient will be aware which procedure was performed.

If results suggest an appropriate safety profile and preliminary effectiveness, then researchers will approach the University at Buffalo Institutional Review Board (IRB) for an extension of the protocol to study a larger number of patients in order to convincingly prove or disprove a causal relationship between CCSVI and MS.

If angioplasty is proven effective at improving MS symptoms, the resultant implications for the future of MS treatment could be monumental. The physicians conducting PREMiSe are cautious but optimistic that initial findings will be promising.

http://www.prweb.com/releases/2010/06/prweb4199404.htm

So far the only media outlet that has picked up this US news press release is CTV in Canada....
link to press

cheerleader wrote:So far the only media outlet that has picked up this US news press release is CTV in Canada....
[colo=blue] link to press [/color]

Unfortunately not a surprise. There probably won't be any US coverage of this.

I am very happy for the news.

After I read the text I keep wondering about this "there will be no inflation of the balloon". I mean, what kind of sham procedure would it be? Ballon's inflation is not noticeable by the patient?
I suppose placebo people won't be given anticoagulants, then, wouldn't they notice that they didn't get bruises more easily than before?

I know, nitpicking, but anyway....

It's possible that the pts will all be more heavily sedated to preserve the blinding.

Furthermore it's also highly probable that no one will receive anticoagulants, because stents are not being used. Drs Siskin and Mandato do not use them, and when I emailed Dr. Mandato about it, he emphasized that anticoagulants are not indicated after angioplasty alone. I know dr. Sclafani disagrees, but you can see that there is a different point of view out there.

I think this trial will be the key to unlocking future studies and leading to other IRB approvals. Unfortunately it's a small cohort so any results will be viewed with that in mind.

I think it's a good thing that the cohort is so small, as it means that only a small group gets the sham procedure. If the results are clear (positive or negative), they won't have to do any more. If they are unclear, then still can do some more.

cah wrote:I think it's a good thing that the cohort is so small, as it means that only a small group gets the sham procedure. If the results are clear (positive or negative), they won't have to do any more. If they are unclear, then still can do some more.

Statistically, they guaranteed cannot be significant, ie "clear". That is why they need a Phase II and then a larger study.